BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERRA II IPG

    MDR report key: 20634654 · Received November 7, 2024

    Report

    Report Number
    3027386225-2024-00143
    Event Type
    Death
    Date Received
    November 7, 2024
    Date of Event
    October 17, 2024
    Report Date
    September 29, 2025
    Manufacturer
    ENTERRA MEDICAL, INC.
    Product Code
    LNQ
    UDI-DI
    00763000449704
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RECIEVED DEVICE FROM FUNERAL HOME. PATIENT WAS (B)(6). CAUSE OF DEATH WAS UNCONTROLLED DIABETES RESULTING IN CARDIAC ARREST.

    Description of Event or Problem · 0

    DEATH. PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS - REPORTED IN MEDTRONIC DATABASE. RECEIVED STICKER ON RETURNED IPG - TEXT: "CP #(B)(4); DOD (B)(6) 2024; TOD 0150; REMOVED FOR CREMATION" IMPLANTED (B)(6)2015. LEADS RECEIVED CONNECTED TO DEVICE AND SEGMENTED AT PROXIMAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814813 ENTERRA II IPG GASTRIC STIMULATOR LNQ ENTERRA MEDICAL, INC. 37800 00763000449704

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Death